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Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Hospital Universitario Virgen de la Arrixaca.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier:
NCT00782457
First received: October 29, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  Purpose

The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.


Condition Intervention Phase
Rectal Cancer
 Procedure: RECTAL CANCER RESECTION
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Hospital Universitario Virgen de la Arrixaca:

Primary Outcome Measures:
  • Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2002
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: OPEN SURGERY Procedure: RECTAL CANCER RESECTION
Experimental: LAPAROSCOPIC SURGERY Procedure: RECTAL CANCER RESECTION

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)
  • Histology of adenocarcinoma

Exclusion Criteria:

  • Locally advanced disease (T4)
  • Emergency surgery
  • Rectal cancer over familial colic polyposis
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided by Hospital Universitario Virgen de la Arrixaca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Juan Lujan, HUV Arrixaca
ClinicalTrials.gov Identifier: NCT00782457     History of Changes
Other Study ID Numbers: D-08-00770
Study First Received: October 29, 2008
Last Updated: October 29, 2008
Health Authority: Spain: Ethics Committee

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 22, 2013